NCT00769769

Brief Summary

This study will compare the effectiveness of face-to-face cognitive behavioral therapy versus telephone-based cognitive behavioral therapy for treating African Americans who care for family members with dementia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for phase_3 depression

Timeline
Completed

Started Oct 2008

Typical duration for phase_3 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

3.3 years

First QC Date

October 8, 2008

Last Update Submit

August 22, 2013

Conditions

Keywords

Health Status

Outcome Measures

Primary Outcomes (1)

  • Depression clinical diagnosis

    Measured before and after 3-month intervention

Secondary Outcomes (1)

  • Caregiver health status

    Measured before and after 3-month intervention

Study Arms (2)

Telephone-based psychotherapy

EXPERIMENTAL
Behavioral: Psychotherapy

Face-to-face psychotherapy

ACTIVE COMPARATOR
Behavioral: Psychotherapy

Interventions

PsychotherapyBEHAVIORAL

Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.

Face-to-face psychotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provides significant care for a spouse, parent, or relative who meets National Institute of Neurological and Communicative Disorders and Strokes-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable dementia
  • Provides care for a relative 60 years of age or older with progressive dementia
  • Primary informal care provider for the care recipient with dementia
  • Spends a minimum of 6 hours per week in providing direct care to the person with progressive dementia
  • Scores a minimum of 10 on the Patient Health Questionnaire-9 (PHQ-9)

You may not qualify if:

  • Endorses fewer than three problems on the depression and disruptive behaviors factors of the modified version of Revised Memory and Behavior Problem Checklist
  • Meets criteria for psychotic disorder on the Mini-International Neuropsychiatric Interview (MINI 5.0.0)
  • Meets criteria for moderate or high suicide risk on the MINI 5.0.0
  • Provides care for a dementia care recipient who has received a terminal diagnosis of 6 months, as defined by hospice care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University College of Medicine

Tallahassee, Florida, 32306-4300, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Robert L. Glueckauf, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 23, 2013

Record last verified: 2013-08

Locations